Brilliance iCT; Product Code (REF): 728306;
| Source | FDA Device Enforcement |
|---|---|
| Category | Medical Device |
| Severity | Medium |
| Status | ongoing |
| Recall date | January 07, 2026 |
| Reported | February 18, 2026 |
| Recalling firm | Philips North America Llc |
| Country / region | United States MA |
Hazard
As part of the CT systems sub assembly, thirty-two (32) fasteners are used to attach the rotor to the bearing within the gantry. One or more of these fasteners may not be torqued to specification. If multiple fasteners are not torqued to specification, the rotor or rotor parts may become unsecured or displaced. While there has been no reported or observed event of expelled parts during gantry rotation, unsecured rotor parts may potentially be expelled.
Affected products
- Brilliance iCT; Product Code (REF): 728306;
Related recalls
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